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U.S. Department of Health and Human Services

Class 2 Device Recall Triathlon X3 UHMWPE Tibial Inserts and Patellar Components

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 Class 2 Device Recall Triathlon X3 UHMWPE Tibial Inserts and Patellar Componentssee related information
Date Initiated by FirmFebruary 17, 2006
Date PostedMarch 02, 2010
Recall Status1 Terminated 3 on March 03, 2010
Recall NumberZ-0910-2010
Recall Event ID 50150
510(K)NumberK031729 
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
ProductTriathlon X3 UHMWPE Tibial Inserts and Patellar Components, multiple sizes, Stryker Orthopaedics, Mahwah, NJ. Intended to be used with femoral components in primary or revision total knee arthroplasty.
Code Information Lot Numbers: 36325001; 36325102;36325302; 36325402; 36325602; 36326002; 36326201;33936308; 36605501; 36326601; 33934303; 33934705; 36327201; 36327301; 36327401; 36328101; 35453302; 36378501; 36604001; 36379001; 36379101; 36379201; 36379301; 36379401; 36604301; 36379501; 36604502; 36379901; 36326301; 36380001; 36380101; 35728201; 36380401; 36380601; 36380901; 36381201; 36381401; 35730101; 36381601; 35730602; 35921201; 35921301; 36382001; 35730801; 35730802; 35730803 and 36382101.
Recalling Firm/
Manufacturer		 Stryker Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah NJ 07430
For Additional Information ContactKaren Ariemma, RAC
201-831-5718
Manufacturer Reason
for Recall		Stryker Orthopaedics became aware of a potential anomaly related to the packaging process of referenced lots of X# polyethylene used on Scorpio, Triathlon and Trident inserts.
FDA Determined
Cause 2		Process design
ActionStryker Orthopaedics issued an "Important Market Withdrawal" notification dated February 17, 2007 via federal express. Consignees were informed of the affected product and asked to retrieve, reconcile and return product via Return Material Authorization to the firm. For further information, contact Stryker Orthopaedics Quality Assurance at 1-201-831-5825.
Quantity in Commerce594 units total - all products.
DistributionWorldwide Distribution -- United States and Canada.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = JWH
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